On August 15, 2022 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported financial results for the second quarter ended June 30, 2022 (Press release, Ideaya Biosciences, AUG 15, 2022, View Source [SID1234618312]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The IDE397 program is at a key inflection point, and as a wholly-owned program, is uniquely positioned for value accretion as we initiate monotherapy expansion and combination cohorts. Our clinical trial collaboration with Amgen enables clinical evaluation of IDE397 in combination with AMG 193, Amgen’s investigational MTA-cooperative PRMT5 inhibitor, a potential first-in-class combination inhibiting two complementary synthetic lethal nodes within the MTAP pathway. The clinical ctDNA molecular response data from the IDE397 monotherapy dose escalation demonstrates target engagement and tumor pharmacodynamic modulation, and provides additional data on clinical activity," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"We look forward to providing the interim Phase 2 clinical data update for darovasertib and crizotinib synthetic lethal combination in first-line and any-line MUM patients in September 2022. This clinical data update will include, confirmed ORR by RECIST, median PFS, median duration-of-response, and an adverse event summary. We will also provide an update on a potential registrational path in MUM, and share observations supporting clinical proof of concept for potential use of darovasertib in the (neo)adjuvant UM setting," continued Mr. Hata.

"We have a pipeline of potential first-in-class synthetic lethality therapeutics advancing toward the clinic. We are targeting an IND in Q4 2022 for IDE161, our PARG inhibitor, for patients having tumors with HRD. In collaboration with GSK, we are targeting first-in-human clinical evaluation in H1 2023 for our Pol Theta Helicase development candidate in combination with niraparib for patients having tumors with HRD, and our Werner Helicase program with GSK continues to be on track for development candidate nomination in 2023," said Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA Biosciences.

Program Updates
Key highlights for IDEAYA’s pipeline programs include:

IDE397 (MAT2A)
IDEAYA is clinically evaluating IDE397, a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, a patient population estimated to represent approximately 15% of solid tumors. IDEAYA is continuing clinical development of IDE397 in its Phase 1/2 clinical trial, IDE397-001 (NCT04794699). Highlights:

Patients are being identified by next generation sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS

Initiated monotherapy expansion cohorts with enrollment open for NSCLC and esophagogastric tumors with MTAP deletion

Initiated combination dose escalation cohorts with enrollment open for combinations with docetaxel in NSCLC, paclitaxel in esophagogastric cancer, and with pemetrexed in NSCLC and potentially other solid tumors

Entered into Clinical Trial Collaboration and Supply Agreement with Amgen to clinically evaluate IDE397 MAT2A inhibitor in combination with AMG 193, Amgen’s investigational small molecule MTA-cooperative inhibitor of PRMT5, in MTAP-null solid tumors

Delivered IDE397 option data package to GSK comprising preclinical data and clinical data from the monotherapy dose escalation study of the Phase 1 clinical trial, including safety and tolerability data, pharmacokinetic and pharmacodynamic data

Retained and fully own all right, title and interest in and to IDE397 and the MAT2A Program, following receipt of notice from GSK waiving its rights to exercise its option to obtain an exclusive license to further develop and commercialize IDE397, as well as other IDEAYA compounds, if any, directly targeting MAT2A

Wholly-owned Phase 2 clinical asset, IDE397 provides company with additional strategic optionality as monotherapy and combination therapies advance

Strategic rationale of the IDE397 collaboration with GSK became less compelling for IDEAYA following GSK termination of its internal PRMT5 and Type 1 PRMT clinical programs, each of which was contemplated as a potential combination partner with IDE397 when the partnership was formed in June 2020

IDEAYA is sufficiently capitalized to execute the IDE397 Phase 2 clinical program

Demonstrated IDE397 clinical tumor pharmacodynamic modulation based on ctDNA Molecular Responses observed in thirteen evaluable patients with liquid biopsy samples available at baseline and after first treatment cycle, including:

31% (n=4 of 13) of evaluable patients treated with IDE397 across all dose escalation Cohorts 1 thru 6 observed ctDNA molecular responses

75% (n=3 of 5) of evaluable patients treated with IDE397 at higher doses in Cohorts 5 and 6 observed ctDNA molecular responses

100% (n=2 of 2) of evaluable NSCLC patients observed ctDNA molecular responses
Darovasertib (PKC)
IDEAYA continues to advance its Phase 1/2 clinical trial evaluating darovasertib (IDE196), a potent and selective PKC inhibitor, in combination with crizotinib, a cMET inhibitor, in metastatic uveal melanoma (MUM). The company is also clinically evaluating darovasertib as a combination with crizotinib in GNAQ/11 mutant skin melanoma in an ongoing arm of the current clinical trial, and in (neo)adjuvant uveal melanoma (UM) as monotherapy through an investigator sponsor clinical trial (IST).

IDEAYA is planning to initiate a company-sponsored clinical trial to evaluate darovasertib in (neo)adjuvant uveal melanoma. The company is also evaluating other potential darovasertib expansion opportunities, including in cMET driven tumors and in KRAS-mutation tumors.

Darovasertib / Crizotinib Combination Therapy in Metastatic Uveal Melanoma (MUM)
IDEAYA is continuing patient enrollment into the darovasertib / crizotinib combination arm of the Phase 1/2 clinical trial under clinical trial collaboration and supply agreements with Pfizer. Highlights:

IDEAYA presented preliminary darovasertib and crizotinib clinical combination data in December 2021. The reported preliminary data, based on an unlocked database, showed robust clinical activity, including 31% ORR (n=4 of 13 evaluable) in heavily pre-treated MUM patents, with manageable side effect profile

Historical % ORR and median PFS by other therapies in MUM have been low, including ranging from 0% to 5% ORR and 2 to 3 months median PFS

Prioritizing enrollment of additional first-line MUM patients based on observed early clinical partial responses

Targeting interim Phase 2 clinical results for darovasertib and crizotinib synthetic lethal combination in first-line and any-line MUM patients in September 2022, including:

clinical efficacy in MUM based on confirmed overall response rate by RECIST, median progression-free survival, median duration of response and adverse event summary

potential registrational path for darovasertib and crizotinib combination in MUM

clinical proof of concept for potential use of darovasertib in (neo) adjuvant UM

In April 2022, the FDA designated darovasertib as an Orphan Drug in Uveal Melanoma, including MUM

Collaborating with Pfizer under a clinical collaboration and supply agreement to support clinical evaluation of darovasertib and crizotinib combination in a potential registration-enabling clinical trial in MUM, subject to FDA feedback and guidance
Darovasertib – (Neo)Adjuvant Uveal Melanoma (UM)
IDEAYA is evaluating the potential for darovasertib in neoadjuvant and/or adjuvant uveal melanoma. Highlights:

(Neo)adjuvant UM represents a significant expansion opportunity – with a potential annual incidence of approximately 6,400 patients aggregate in US and Europe

IDEAYA has initiated an Investigator Sponsored Trial with St. Vincent’s Hospital Sydney Limited to evaluate darovasertib as monotherapy in a neo-adjuvant and/or adjuvant setting in uveal melanoma patients
Darovasertib – Other Potential Indications
IDEAYA is evaluating the potential for darovasertib in other oncology indications, including in cMET-driven tumors and RAS-mutation tumors. Highlights:

Collaborating with Pfizer under a clinical collaboration and supply agreement for clinical evaluation of darovasertib and crizotinib combination therapy in cMET-driven tumors, such as NSCLC or HCC; targeting initiation of a Phase 1/2 clinical trial in the first quarter of 2023

Evaluating darovasertib in combination with a KRAS inhibitor in preclinical studies in KRAS-driven solid tumors
PARG
IDEAYA is advancing preclinical research for an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) in patients having tumors with a defined biomarker based on genetic mutations and/or molecular signature. PARG is a novel target in the same clinically validated biological pathway as poly (ADP-ribose) polymerase (PARP). IDEAYA owns or controls all commercial rights in its PARG program. Highlights:

Ongoing IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor development candidate for patients having tumors with homologous recombination deficiencies (HRD), including BRCA1 and BRCA2, and potentially other alterations

Targeting IND for IDE161 in the fourth quarter of 2022

Considering potential development approaches based on observed activity of IDE161 in PARPi resistant and/or platinum-resistant tumors, differentiated sensitivity relative to PARP inhibitors, and improved preliminary safety profile relative to PARP inhibitors
Pol Theta
IDEAYA’s DNA Polymerase Theta, (Pol Theta) program targets tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD). IDEAYA and GSK are collaborating on ongoing preclinical research, including small molecules and protein degraders, and GSK will lead clinical development for the Pol Theta program. Highlights:

Selected a potential first-in-class Pol Theta Helicase development candidate in collaboration with GSK

Observed complete responses in preclinical combination studies of Pol Theta Helicase DC with niraparib in multiple in vivo PDX and CDX HRD models

Targeting first-in-human clinical evaluation of Pol Theta Helicase DC combination with niraparib in H1 2023 for patients having tumors with HRD

IDEAYA is eligible to receive future development and regulatory milestones of up to $485 million aggregate from GSK:

Preclinical and clinical milestones of up to $20 million in aggregate for advancing a Pol Theta Helicase inhibitor from preclinical to early Phase 1 clinical, including up to $10 million aggregate through IND effectiveness
Werner Helicase
IDEAYA is advancing preclinical research for an inhibitor targeting Werner Helicase for tumors with high microsatellite instability (MSI). IDEAYA and GSK are collaborating on ongoing preclinical research, and GSK will lead clinical development for the Werner Helicase program. Highlights:

Targeting selection of a Werner Helicase development candidate in 2023

Potential for up to $20 million in aggregate milestone payments from GlaxoSmithKline for advancing a Werner Helicase inhibitor from preclinical to early Phase 1 clinical
Other Synthetic Lethality Pipeline Programs
IDEAYA is advancing additional preclinical research programs to identify small molecule inhibitors for an MTAP-synthetic lethality target, as well as for multiple potential first-in-class synthetic lethality programs for patients with solid tumors characterized by proprietary biomarkers or gene signatures.

General
IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Initiation of clinical trial sites, patient enrollment and ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted for IDEAYA clinical trials evaluating IDE397 and darovasertib; the specific impacts are currently uncertain.

Corporate Updates
IDEAYA’s net losses were $22.1 million and $14.0 million for the three months ended June 30, 2022 and March 31, 2022, respectively. As of June 30, 2022, the company had an accumulated deficit of $212.8 million.

As of June 30, 2022, IDEAYA had cash, cash equivalents and marketable securities of $323.8 million. IDEAYA believes that its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into 2025. These funds will support the company’s efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs.

Our updated corporate presentation is available on our website, at our Investor Relations page: View Source

Financial Results
As of June 30, 2022, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $323.8 million. This compared to cash, cash equivalents and short-term and long-term marketable securities of $346.2 million at March 31, 2022. The decrease was primarily due to cash used in operations.

Collaboration revenue for the three months ended June 30, 2022 totaled $5.9 million compared to $11.4 million for the three months ended March 31, 2022. Collaboration revenue was recognized for the performance obligations satisfied through June 30, 2022 under the GSK Collaboration Agreement.

Research and development (R&D) expenses for the three months ended June 30, 2022 totaled $22.8 million compared to $19.7 million for the three months ended March 31, 2022. The increase was primarily due to higher personnel-related expenses, clinical trial expenses and outside services.

General and administrative (G&A) expenses for the three months ended June 30, 2022 totaled $5.6 million compared to $5.9 million for the three months ended March 31, 2022. The decrease was primarily due to lower personnel-related expenses and outside services.

The net loss for the three months ended June 30, 2022 was $22.1 million compared to $14.0 million for the three months ended March 31, 2022. Total stock compensation expense for the three months ended June 30, 2022 was $3.0 million compared to $2.6 million for the three months ended March 31, 2022.

On August 15, 2022 Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported that its collaboration agreement with Indivior PLC (LON: INDV) for discovering and developing novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates has been extended until March 31, 2023 (Press release, Addex Therapeutics, AUG 15, 2022, View Source [SID1234618311]). As part of the amended agreement, Indivior will provide Addex with CHF 850,000 (approx. US $900,000) of additional research funding. The reserved indications, where Addex retains exclusive rights to develop its own independent GABAB PAM program, have also been expanded to include chronic cough, in addition to the rights to develop certain retained compounds for Charcot-Marie-Tooth type 1A neuropathy (CMT1A) and pain.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have advanced the GABAB PAM program into the late stage of clinical candidate selection and are currently selecting compounds for entry into IND enabling studies for both Indivior’s program in substance use disorder and Addex’s independent programs for CMT1A, chronic cough and pain," said Mikhail Kalinichev, Head of Translational Science of Addex. "This additional research funding demonstrates the progress made to date in identifying novel GABAB PAM drug candidates and reflects the promise this mechanism of action has to bring significant benefit to the quality of life of patients".

"Indivior continues to be an important strategic partner for Addex as we continue to advance our preclinical portfolio towards the clinic and await the readout from the ADX71149 Phase 2 epilepsy study being conducted by our partner, Janssen Pharmaceuticals Inc., which is due to report top line data at the end of 2022," said Tim Dyer, CEO of Addex. "We also continue to advance discussions with potential partners across our portfolio and evaluate the future development path for dipraglurant, our mGlu5 NAM clinical program."

About GABAB Activation with PAM

Activation of gamma-aminobutyric acid subtype B (GABAB) receptor, a Family C class of GPCR, is clinically and commercially validated. The generic GABAB receptor agonist, baclofen, marketed for spasticity and some spinal cord injuries, has been shown to be efficacious in several other disease areas, including alcohol use disorder, CMT1A, chronic cough and pain. However, its wider use is limited due to a variety of side effects, rapid clearance and the development of tolerance. Novel, potent, selective and orally available positive allosteric modulators (PAMs) that potentiate GABA responses, rather than acting as orthosteric agonists at the GABAB receptor, like baclofen, are expected to deliver efficacy and have less adverse effects. Furthermore, PAMs only act when the natural ligand (GABA) activates the receptor, hence respecting the physiological cycle of activation, which is believed to explain why PAMs lead to less tolerance than direct agonists.

On August 15, 2022 Celleron Therapeutics, the UK-based company developing innovative precision cancer medicines, reported that in partnership with the Chinese University of Hong Kong it has successfully received a study grant from the Hong Kong government’s General Research Fund (Press release, Celleron, AUG 15, 2022, View Source [SID1234618310]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The funding will finance the randomised Phase II clinical trial of zabadinostat in liver cancer patients with acquired resistance to immune checkpoint inhibitors (ICIs). This follows compelling pre-clinical studies in mice treated with zabadinostat which restores antigen presentation and boosts the immune response, thereby re-conferring sensitivity to ICIs, resulting in tumour eradication and significantly improved survival.

The highly anticipated clinical trial, which will begin later this year, is designed to test the safety and efficacy of zabadinostat combined with an ICI in checkpoint-resistant liver cancer patients. The Principal Investigator will be Professor Stephen L. Chan from the Department of Clinical Oncology at CUHK, with co-investigators from CUHK and the Prince of Wales Hospital.

David Kerr, CMO of Celleron Therapeutics and Professor of Cancer Medicine at the University of Oxford, commented:

"We are delighted to be collaborating with one of the world’s leading groups on HCC. The extraordinary findings in a highly relevant mouse model give us great confidence that we can recapitulate these results in man and deliver a telling blow to this awful disease. Our sophisticated trial design will give us the necessary clinical data to seek accelerated approval from the regulatory authorities but stays true to our commitment to precision medicine by generating additional potential biomarkers to further improve clinical outcomes".

NOTES:

About HCC Liver Cancer

80% of primary liver cancer cases are Hepatocellular Carcinoma (HCC). HCC is now the fourth leading cause of cancer deaths worldwide, with over 600,000 new cases each year. It occurs predominantly in patients with underlying chronic liver disease and cirrhosis. Tumours progress with local expansion in the liver, followed by spreading to other tissues. The incidence of HCC is highest in Asia and Africa, where the endemic high prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) strongly predisposes to the development of chronic liver disease and subsequent development of HCC.

Surgical resection has the highest survival prognosis. The use of systemic or regional chemotherapy has been attempted in patients with HCC. Unfortunately, HCC is minimally responsive to chemotherapy. The multi-kinase inhibitor, sorafenib was approved in 2007 by the US Food and Drug Administration (FDA) for use in patients with unresectable HCC, followed in 2018 by lenvatinib.

Since 2020, PD-1 immune check-point inhibitors have found increasing clinical use in advanced HCC. Atezolizumab combined with bevacizumab has been approved as a first line therapy; and pembrolizumab, or nivolumab as second-line treatment for patients who have relapsed on sorafenib. Although subsets of patients exhibit durable responses, the development of resistance to checkpoint blockade, and subsequent relapse is common.

On August 15, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the second quarter ended on June 30, 2022 (Press release, Scynexis, AUG 15, 2022, View Source [SID1234618308]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to see the improvements to the current sales trajectory, and we are well capitalized with a cash runway into the first quarter of 2024 to execute on the next important steps toward our goal of building a broad, long-lasting antifungal franchise," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "For the remainder of the year we will be focused on preparing for the approval of the recurrent VVC indication, while working to enroll invasive candidiasis patients into our MARIO study."

BREXAFEMME Commercial Update

BREXAFEMME delivered $1.3 million in net sales in Q2 2022. According to IQVIA data, there were approximately 5,141 total prescriptions for BREXAFEMME written in Q2 2022, a 29 percent increase of total prescriptions over Q1 2022.
BREXAFEMME was prescribed by over 2,200 individual healthcare professionals (HCPs) in the second quarter, an increase of 25% over Q1 2022.
Commercial insurance coverage of BREXAFEMME continues to expand. As of June 2022, BREXAFEMME was covered by plans representing more than 109 million or 60% of commercially-insured lives, a 17% increase over the 93 million covered lives as of Q1 2022.
Ibrexafungerp Clinical Updates

In August 2022, SCYNEXIS announced that the U.S. Food and Drug Administration (FDA) accepted the Company’s submission of a supplemental NDA for a labelling expansion for BREXAFEMME for the prevention of recurrent VVC. The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.
Initiated enrollment in MARIO, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC) in the hospital setting. SCYNEXIS anticipates study completion and results to enable regulatory filing and potential approval for IC, including candidemia, in 2024. If approved, oral ibrexafungerp would be the first non-azole oral therapy available for invasive candidiasis and would enable an IV-to-oral transition with a consistent mechanism of action. Like IV-only echinocandins, oral ibrexafungerp acts via glucan synthase inhibition, a mechanism which has been demonstrated to be the most effective for treating invasive Candida infections.
Initiated enrollment in a new Phase 3b, open-label, multicenter study (VANQUISH) to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a treatment for vulvovaginal candidiasis (VVC) in patients who have failed treatment with fluconazole, based on mycological and clinical outcomes. The VANQUISH study will enroll approximately 150 patients with complicated VVC who have failed fluconazole treatment and who will receive 600 mg of oral ibrexafungerp for one, three or seven consecutive days determined by their underlying complicating condition including immunocompromised state. Complicated patients include patients with recurrent VVC, those with VVC caused by non-albicans Candida species, and those with diabetes, immunocompromising conditions (e.g., HIV), or immunosuppressive therapy (e.g., corticosteroids).
Achieved target enrollment of 200 patients for its Phase 3 FURI study evaluating oral ibrexafungerp for the treatment of patients with severe fungal infections who are either intolerant to standard antifungal therapy or experience refractory fungal infections despite treatment, including those caused by Candida auris (C. auris). SCYNEXIS anticipates study closure activities to commence by the end of 2022 and also is on track to complete enrollment in the CARES trial during second half of 2022.
Following the positive Phase 1 data with the IV formulation reported previously, SCYNEXIS is preparing for discussions with FDA regarding the next stage of development.
Ibrexafungerp Scientific Presentations and Publications

Presented positive outcomes from its global Phase 3 CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (RVVC), also known as vaginal yeast infection. The results were presented during the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting held in Boston August 4-6, 2022. The study met its primary endpoint, with 65.4% of patients who received monthly single-day ibrexafungerp treatment achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected, through Week 24. In addition, ibrexafungerp demonstrated superiority over placebo in preventing mycologically proven recurrence of RVVC through Week 24, a key secondary endpoint. No mycologically proven recurrence was detected in 70.8% of patients receiving ibrexafungerp. The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant in both primary and secondary endpoints (p=0.034 and 0.029, respectively). In the study, ibrexafungerp was generally safe and well-tolerated. There were no serious drug-related adverse events, and no patients treated with ibrexafungerp discontinued therapy due to adverse events. The most commonly-reported adverse events, headaches and gastrointestinal in nature (i.e., diarrhea, nausea), were mostly mild and generally consistent with the current approved product label.
Presented positive outcomes from the CANDLE nested sub-study investigating oral ibrexafungerp in patients with recurrent vulvovaginal candidiasis (RVVC) who failed fluconazole treatment. The results were presented during the International Society for the Study of Vulvovaginal Diseases (ISSVD) XXVI World Congress and International Vulvovaginal Disease Update 2022 held in Dublin, Ireland, July 15-20, 2022. Data show that 71% of 24 patients with recurrent vulvovaginal candidiasis (RVVC) who failed to respond to a three-day regimen of fluconazole achieved a substantial reduction or complete elimination of signs and symptoms after receiving a one-day treatment with ibrexafungerp.
Reported new positive outcomes in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting held in San Diego May 6-8, 2022. Ibrexafungerp showed positive results in difficult-to-treat VVC patients with severe fungal infections who were either intolerant to standard antifungal therapy or experienced refractory infections despite treatment. Of the 14 patients in the FURI study with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. Patients with VVC received 750 mg of oral ibrexafungerp (375 mg twice a day) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7). In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing product label.
Presented positive interim analyses of data from its ongoing Phase 3 FURI and CARES studies at the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held in Lisbon, Portugal April 23-26, 2022. In an interim analysis of the CARES study of 18 enrolled patients with candidemia and other infections caused by Candida auris (C. auris) treated for a mean duration of 18 days, 78% of patients showed complete or partial response and 11% had stable disease. An interim analysis was conducted with combined data of 49 patients with invasive candidiasis and candidemia from the ongoing Phase 3 FURI (n=39) and CARES (n=10) studies. Aggregate data from the two studies showed that of the patients treated with ibrexafungerp, 68% had complete or partial response and 14% had stable disease.
Additional preclinical data presented at ECCMID from an in vivo mouse model of pulmonary mucormycosis support ibrexafungerp as an effective potential treatment for mucormycosis. The study also demonstrated in vivo efficacy of ibrexafungerp monotherapy in treating both Rhizopus delemar and Mucor circinelloides infections in mice, consistent with other antifungals currently used against mucormycosis. Additionally, the study found that when ibrexafungerp was combined with liposomal amphotericin B or posaconazole, synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone (p<0.05).
Corporate Developments

SCYNEXIS raised gross proceeds of $45 million ($42 million net) in an April 2022 public offering of common stock, pre-funded warrants, and warrants.
Second Quarter 2022 Financial Results

BREXAFEMME increased its net product revenues from $0.7 million in Q1 2022 to $1.3 million in Q2 2022.

Research and development expense for Q2 2022 increased to $7.1 million from $4.7 million for Q2 2021.

Selling, general & administrative (SG&A) expense for Q2 2022 increased to $15.8 million from $12.8 million for Q2 2021. The increase was primarily driven by an increase in costs recognized to support the ongoing commercialization of BREXAFEMME.

Total other income was $8.4 million for Q2 2022, versus total other income of $15.0 million for Q2 2021. During Q2 2022 and Q2 2021, SCYNEXIS recognized non-cash gains of $9.7 million and $15.3 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash gains of $0.2 million and $0.5 million, respectively, on the fair value adjustment of derivative liabilities.

Net loss for Q2 2022 was $13.3 million, or $0.31 basic loss per share, compared to a net gain of $1.7 million, or $0.06 basic income per share for Q2 2021.

Cash Balance

Cash and cash equivalents totaled $118.7 million on June 30, 2022, compared to $104.5 million in cash and cash equivalents on December 31, 2021. Based upon its current operating plan, SCYNEXIS believes that its existing cash and cash equivalents, and the anticipated sales of BREXAFEMME, will enable SCYNEXIS to fund its operating requirements into Q1 2024.

Conference call and webcast details

A conference call to discuss the results will be held today at 8:30 a.m. EDT

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration (FDA) granted ibrexafungerp Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On August 15, 2022 Vivesto AB, an oncology-focused specialty pharmaceutical company, reported to note the announcement this morning by Inceptua AB, that it has launched Apealea (paclitaxel micellar) in Germany (Press release, Vivesto, AUG 15, 2022, View Source [SID1234618299]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Vivesto signed a global strategic partnership with US-based Elevar Therapeutics ("Elevar") for the commercialization of Apealea in March 2020 which is now being launched in Germany through Elevar’s European partner Inceptua AB ("Inceptua").